A Pragmatic Open Label, Multi-center, Spontaneous, No-profit, Randomized Controlled Clinical Trial With Non-significant Risk Medical Device on the Rotational Use of Interfaces Versus Standard of Care for Patients Treated With NPPV for AHRF.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 478
- 试验地点
- 1
- 主要终点
- Proportion of patients who develop new pressure sores
研究概览
简要总结
In this trial investigators will explore if a protocolized rotational use of interfaces i.e., masks, during noninvasive positive pressure ventilation (NPPV) compared to standard care is clinically effective and cost-effective in reducing the incidence of pressure sores in patients with hypercapnic acute respiratory failure (AHRF) treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation and after early extubation and weaning).
详细描述
Objectives:
Primary objective To determine if a protocolized rotational use of interfaces during NPPV compared to standard care is effective in reducing the development of new pressure sores in patients with hypercapnic ARF treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation, and during early extubation and weaning).
Measurements of effectiveness include:
The primary effectiveness outcome will be the proportion of patients who develop new pressure sores at 36 hours from randomization. Secondary outcomes will be the onset of pressure sores measured at different time points (12, 24, 36, 48, 60, 72, 84, 96 hours), number and stage of pressure sores and comfort measured at the same time points of the primary outcome. The location of pressure sores per patient will be also collected. The study will also monitor the number of patients that will interrupt NPPV treatment for discomfort, the presence of eyes irritation, the adherence to the protocol (duration of NPPV treatment/day, interface change, hygiene protocol application) and the presence of vasoactive medications. Variables like nutritional status at randomization, Braden Scale and Frailty Index at hospital entrance, total duration of NPPV from randomization, duration of NPPV per day, hospital length of stay and in-hospital mortality will be recorded. The economic impact of the protocolized rotational use of interfaces will be assessed through a cost-effectiveness analysis evaluating the additional costs needed to avoid a pressure sore due to the planned intervention as well as the costs needed to actively treat skin ulcers due to failure of preventing measures in both groups of patients.
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years old
- •Patients with chronic obstructive pulmonary disease (COPD) exacerbation or with AHRF of a different etiology needing NPPV to avoid intubation (pH < 7.35 with PaCO2 > 45 mmHg and partial pressure of oxygen (PaO2) < 65 mmHg plus respiratory rate > 25 breath/min with clinical signs of respiratory muscle distress); or as alternative to invasive ventilation with a forecast of treatment of at least 24 hours admitted to the intensive care unit, intermediate respiratory care unit, respiratory medicine service or internal medicine service according to hospital organization; or patients with chronic pulmonary disease intubated for a COPD exacerbation or for pneumonia who are early extubated and weaned in the intensive care unit with NPPV with a forecast of treatment of at least 24 hours.
排除标准
- •Patient with skin breakdown or non-blanchable erythema in one of the following areas i.e., nasal bridge, nasolabial fold, cheek or scalp at hospital entrance;
- •Patients who refuse to consent to the study protocol;
- •Patient known to be pregnant;
- •Patients with contraindication to NPPV (lack of spontaneous breathing; gasping; anatomical or functional airway obstruction; gastrointestinal bleeding or ileus; coma; massive agitation; massive retention of secretions despite bronchoscopy and aggressive physiotherapy; hemodynamic instability (cardiogenic shock, myocardial infarction); status post upper gastrointestinal surgery);
- •Patients entering hospital with asthma, with cardiogenic pulmonary edema;
- •Patients with tracheostomy;
- •Patients needing NPPV only for palliation of symptoms (relief of dyspnea) i.e., category 3 defined by the Task Force on the Palliative Use of NPPV of the Society of Critical Care Medicine;
- •Use of high flow nasal cannula integrated with NPPV for weaning strategy;
- •Pre-existing skin erythematosus diseases;
- •Known hypersensitivity to skin protective devices (i.e., polyurethan films, colloids, foams);
- •More than 2 hours of NPPV application before randomization;
- •Patients already included in the study protocol at an earlier stage of the hospitalization;
- •Refuse to wear NPPV interface due to comfort;
研究组 & 干预措施
Intervention group
In the intervention group the first mask will be randomly chosen between the two most used in that center among those available i.e., oro-nasal, total face or hybrid mask. Thereafter, NPPV mask will be changed every 6 hours, alternating the two different interfaces. Patients wearing oro-nasal masks will receive protective dressings on nasal bridge before starting NPPV.
干预措施: Protocolized rotational use of interfaces (Procedure)
Control group
In the control group, mask will be chosen according to the standard of care of the participating centers among the three types of masks available i.e., oro-nasal, total face or hybrid mask. Patients wearing oro-nasal masks will receive protective dressings on nasal bridge before starting NPPV. Interface will be changed in case of discomfort judged by the patient as unbearable or in case of the presence of a pressure sore.
干预措施: Standard of care (Procedure)
结局指标
主要结局
Proportion of patients who develop new pressure sores
时间窗: At 36 hours from randomization
To determine if a protocolized rotational use of interfaces during NPPV compared to standard care is effective in reducing the development of new pressure sores in patients with AHRF treated continuously i.e., for more than 24 hours, with NIV (to avoid intubation, as alternative to invasive ventilation, and during early extubation and weaning).
次要结局
- Cost-effectiveness analysis(At 12, 24, 36, 48, 60, 72, 84, 96 hours from the randomization)
- Onset of pressure sores at different timepoints(At 12, 24, 36, 48, 60, 72, 84, 96 hours from the randomization)
- Number, stage and location of pressure sores(At 12, 24, 36, 48, 60, 72, 84, 96 hours from the randomization)
- NPPV treatment interruption(At 12, 24, 36, 48, 60, 72, 84, 96 hours from the randomization)
研究者
Rosanna Vaschetto, MD, PhD
Associate Professor
Azienda Ospedaliero Universitaria Maggiore della Carita